regulatory environment for food allergen labelling in...

Regulatory Environment for Food Allergen Labelling in Canada:

Current situation and future perspectives

November, 2008

Prepared by:

Samuel Benrejeb Godefroy, Ph.D.

Bureau of Chemical SafetyFood Directorate

Health Products and Food Branch

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Food Allergies and Celiac Disease

Food allergies affect an estimated 6% of Canadian children and 3-4% of adults.Celiac disease affects approximately 1% of the Canadian population.Celiac Disease is widely under-diagnosed.

A High Priority Public Health Issue ? - Prevalence

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Food Allergies and Celiac Disease

150-200 deaths/year due to food anaphylaxis in North America

Estimated 2.6 deaths/year in Ontario (Largest Canadian province), attributed to Food Anaphylaxis

Celiac disease is linked to multiple affections including osteoporosis and cancerImpacts go beyond family circle: Societal impacts

A High Priority Public Health Issue ? - Impacts

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Food Allergy Incidents: rationale for action

Food Allergy Incidents are preventable

Avoidance is the most effective riskmanagement approach for food allergicconsumers

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Stakeholders: Actors

GovernmentGovernment

ConsumersConsumersFood Food IndustryIndustry

RegulationsRegulationsEnforcementEnforcement

EducationEducation

ResponsibilityResponsibilityChoiceChoiceActionAction

SafeSafe ProductsProductsEducationEducation

InformationInformationOfferOffer of of ChoiceChoice

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Policy Objectives

Enhanced protection to avoid inadvertantconsumption of foods containing the « culpritingredient »:

o Minimize risks associated with inadvertent consumption of undeclared allergens in food;

Avoid undue restrictions on choice for a safeand nutritious food supply:

o Maximize Choices for food allergic consumers

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Tool Box for Risk management

Legislative and Regulatory instruments:o Food and Drugs Act and Regulations and their enforcement

Education, information dissemination

Collaboration between stakeholders: Allergic consumers and the foodindustry (Government plays a facilitation role)o e.g. Improvement of manufacturing practices: codes of practiceo Certification programs

Prevention of food allergy incidents

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Prepackaged foods : Importance of food labels

Consumers depend on the information provided on the label to avoid the food allergen, gluten sources and added sulphites in a prepackaged food.

AVOIDANCEThe Key to Preventing Potentially Serious Health Consequences

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Labeling : Key to identify common allergens

Advisory /Precautionary

labeling

OfIngredients

ChoiceChoice::AllergenAllergen FreeFree

Labeling

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Consumer Surveys indicating importance of labeling:o Canadian Survey 2008: 41.5%

respondents experienced accidental exposure to allergens in their lifetime

From those, 33.6% attributed this accident to complex, incomplete labelling or mislabelling31.9% attributed this accident to failure to read the label6.3% to ignoring a precautionary statement

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labeling

OfIngredients


Labeling

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Current Labelling Regulations

The Food and Drug Regulationsrequire that a complete and accurate list of ingredients appear on the label of most prepackaged foods

In most cases, the list of ingredients must include the components of ingredients (i.e. ingredients of ingredients).

Certain ingredients are exempt from component declaration.

Some prepackaged foods do not require a list of ingredients

Ingredient names do not always reflect the “source” of the ingredient

Current Requirements Gaps

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Regulatory Amendments

To require the mandatory “source” declaration of the common food allergens and gluten using simple, plain language in English and Frencho Including allergens and gluten present in components of ingredients

that are currently exempt from component declaration.

To enhance the declaration of sulphites when present in the prepackaged food in a total amount of 10 ppm or more. Scope: Applicable for all ingredients intentionally added to prepackaged foods.

Primary Objectives

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Proposed Regulatory Amendments

Almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts

Peanuts

Sesame seeds

Wheat, kamut, spelt, triticale

“Food Allergen” DefinedAny protein from any of the following foods or any modified

protein, including any protein fraction, that is derived from the following foods:

EggsMilkSoybeansCrustaceaFishShellfish

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Wheat, spelt, kamut

Oats

Barley

Rye

Triticale

“Gluten” DefinedAny gluten protein from the grain of any of the following cereals or the grain of a hybridized strain created from at least one of

the following cereals :

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Sources of common food allergens and gluten must be declared either

o in the list of ingredients,

ORo in the statement: “Allergy and Intolerance Information – Contains:”

Sulphites must be declared

o in a statement “Allergy and Intolerance Information – Contains:” when present at levels of 10 ppm or higher

All current requirements for ingredient declaration remain valid

Label Declaration

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Regulatory Amendments

For products which do not require a list of ingredients but which choose to add an ingredient list, the list will have to be complete and accurate for food allergens, gluten sources and sulphites

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Common names of starches, modified starches, hydrolyzed protein and lecithin would now be modified as follows :

The name of the source of protein be identified in the common name of all hydrolyzed proteinsThe name of the plant source be identified in the common name of all forms of starch or modified starchThe name of the source of lecithin be identified in the common name of lecithin.

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Next Steps

Publication in CGI – in July 2008

Health Canada response to public commentso Early 2009

Preparation of final version of amendments

Publication in Canada Gazette Part IIo By January, 2010

New regulatory amendments enacted with a one year transition period.

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labeling

OfIngredients


Labeling

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In Canada, « may contain » labeling was identified as a judicious risk management measure

o To address instances of « unavoidable » cross- contamination or cross-contact during food processing

o To alert allergic consumers of the « unsuitability of the product » for their condition and of a possible risk

o Statement differs from a « contains » statement, however risk may be identical

“may contain”: Why and when?

Precautionary Labeling

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Current studies show instances of over-use / mis-use of precautionary statements, which impact on foodallergic consumers:

o Precautionary statements…No longer provide meaningful information to allergic

consumers or their family/social circlesCan lead to allergic incidents (warning statements do not clearly reflect the risk level and/or are misinterpreted or ignored)Can unnecessarily limit their food choices

Precautionary labelling : Now !

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Precautionary labelling : Truthful /Helpful ?

Ingredient list much shorter than allergen precautionary statement

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What does it mean ?

Risk? /No risk ?

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Health Canada recently surveyed (2007) chocolateand granola bars…o The most common PS found was « May contain traces

of… »

o Levels of food allergens found varied widely, from non- detected to 6 500ppm (or 0.65%) in a chocolate product which consistently used « may contain traces »:

- The word « traces » can be misleading- Corroborate the fact that allergic consumers must

avoid products with PS

Precautionary labelling: what’s in the products?

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A Canadian suvey (2008) conducted among allergicconsumers showed that:o The most deterring statement was « Not suitable for people with an

allergy to X » (93% would never purchase)

o « May contain X» and « Manufactured on same equipment… » had also good deterring power (87% would never puchase)

o « May contain traces of X » and « Packaged/Manufactured in a facility that also… » were least likely to result in avoidance (72%)

Consumer behaviour surveys

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POLICY REVIEW OBJECTIVE

Reinstating the use of precautionary statements as a meaningful and effective risk management tool in order to:

o minimize risks associated with inadvertent consumption of undeclared priority allergens in food; and

o maximize available choice of safe and nutritious foods for consumers with food allergies and celiac disease.

Precautionary labeling: “may contain”

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The renewed policy on precautionary labeling would:o Restrict statements from a short list of precautionary

statements (PS) : Any other PS than those on the short list would be consideredmisleading and enforcement would take place if they are used

o Mandate the justification of the use of precautionary labelingi.e. documentation of the reasons invoked by the manufacturer/processor to use PS as a risk mitigating tool

o Be complemented by the development and implementation of:Education initiatives (consumers/industry)A code of practice on allergens handling

Proposed option for policy change

Food Allergies : Precautionary Labeling

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labeling

OfIngredients


Labeling

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Providing Choice: « Allergen Free Foods »

Food Allergic Consumers are asking for foods clearly identifiedas being suitable and safe for their conditionsArea of « Special Purpose foods »Considered as a rising segment in agri-food innovation

Consideration for change:o Regulatory frameworks:

« Gluten Free » foods covered by national and international standardsOther regulations ?

o Consideration for change using a pre-market oversight.

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Food Allergic Consumers

Enhanced Protection

EnhancedEnhanced LegislativeLegislative / / RegulatoryRegulatory frameworksframeworksRegulationsRegulations adaptable to science and consumer changesadaptable to science and consumer changes

ConsumersConsumers awareaware of of RisksRisksConsumersConsumers awareaware of of choiceschoices

ImprovedImproved foodfood processingprocessing practicespracticesFood Food DestinedDestined to to allergicallergic communitycommunity

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Merci !

T h a n k - y o u !

T h a n k -y o u !

For more information, please visit us @

www.healthcanada.gc.ca/foodallergies

www.inspection.gc.ca/english/fssa/fssae.shtml

Thank-you!

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THANK YOU FOR YOUR ATTENTION

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